The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The Ceralas Multiwavelength 980/1470nm Diode Laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein. The Multiwavelength laser is further indicated for laser assisted lipolysis.

The device is specifically indicated for use as follows:

Ear, Nose and Throat and Oral Surgery (Otolaryngology)
Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:

Removal of benign lesions from the ear, nose and throat
Excision and vaporization of vocal cord nodules and polyps
Incision and excision of carcinoma in situ
Ablation and vaporization of hyperkeratosis
Excision of carcinoma of the larynx
Laryngeal papillomectomy
Excision and vaporization of herpes simplex I and II
Neck dissection

Arthroscopy
Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:

Menisectomy
Synovectomy
Chondromalacia

Gastroenterology
Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:

Hemostasis of upper and lower GI bleeding
Excision and vaporization of colorectal carcinoma
Excision of polyps

General Surgery, Dermatology, Plastic Surgery and Podiatry
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:

Matrixectomy
Excision of neuromas
Excision of periungual and subungual warts
Excision of plantar warts
Excision of keloids
Liver resection
Excision of cutaneous lesions
Hemorrhoidectomy
Appendectomy
Debridement of decubitus ulcers
Hepatobiliary tumors
Mastectomy
Dermabrasion
Vaporization and hemostasis of capillary hemangioma
Excision, vaporization and hemostasis of abdominal tumors
Excision, vaporization and hemostasis of rectal pathology
Pilonidal cystectomy
Herniorapphy
Adhesiolysis
Parathyroidectomy
Laparoscopic cholecystectomy
Thyroidectomy
Resection of organs
Debridement of wounds
Photocoagulation of teleangectasia of the legs and face
Photocoagulation of vascular lesions of the face and extremities
Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
Treatment of reticular veins and branch varicosities

Urology
Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include:

Vaporization of urethral tumors
Release of urethral stricture
Removal of bladder neck obstruction
Excision and vaporization of condyloma
Lesions of external genitalia
Vaporization of the prostate to treat benign prostatic hyperplasia (BPH)

Gynecology
Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:

Endometrial ablation
Excision or vaporization of condylomata acuminate
Vaporization of cervical intraepithelial neoplasia
Cervical conization
Menorrhagia

Neurosurgery
Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas

Cardiac Surgery
Hemostasis and coagulation of soft tissue, including cardiac tissue.

Pulmonary Surgery
Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:

Tracheobronchial malignancy or stricture
Benign and malignant pulmonary obstruction
Endoscopic pulmonary applications

Dental Applications
Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux
Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

Device Description

The Ceralas Multiwavelength 980/1470 Diode Laser emits laser energy at the 980nm and 1470nm wavelengths in a manner substantially similar to the Ceralas 980 and Ceralas 1470.

AI/ML Overview

The provided text is a 510(k) summary for the Biolitec Ceralas Multiwavelength 980/1470nm Diode Laser System. It outlines the device's intended use, indications, technological characteristics, and a statement of substantial equivalence to predicate devices. However, it does not contain the specific information required to complete most of your request regarding acceptance criteria and a detailed study proving performance.

Here's an analysis based on the available text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity, or specific physical parameters with defined thresholds). Instead, it relies on the concept of substantial equivalence to predicate devices.

The "Performance Data" section merely states:
"Performance testing of the Ceralas Multiwavelength 980/1470 Diode Laser demonstrates no significant difference as compared to the cleared predicate devices."

This implies that the device's performance characteristics (e.g., power output stability, wavelength accuracy, safety features) were tested and found to be sufficiently similar to those of the predicate devices. However, the exact metrics and their values are not provided.

Table of Acceptance Criteria and Reported Device Performance:

Performance Metric / Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Overall Performance	No significant difference compared to cleared predicate devices.	No significant difference compared to cleared predicate devices.
(Specific numerical criteria for power, wavelength, safety, etc., are not provided in this document)	(Not specified)	(Not specified)

Study Details Based on the Provided Text:

Based on the provided 510(k) summary, the device passed its regulatory review by demonstrating substantial equivalence to previously cleared devices. This type of submission generally does not involve a detailed clinical trial with efficacy endpoints in the same way a PMA submission would, nor does it typically involve AI-specific evaluation criteria.

Here's a breakdown of the requested information, indicating where the document lacks specific details:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- The document does not describe a specific "test set" in the context of clinical or performance data for the device. The evaluation was based on demonstrating that the new device has "no significant difference" in performance compared to predicate devices, which likely involved engineering and bench testing rather than a large clinical study with a defined test set of imaging data. Therefore, details about data provenance, retrospective/prospective nature, or sample size are not applicable as described in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. The document does not describe a "test set" requiring human expert-established ground truth. The comparison is based on the technical specifications and operational characteristics of the laser system relative to its predicates.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable for the same reasons as above.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a diode laser system for surgical procedures, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance would not be relevant to this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (a laser system), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of clinical image assessment or AI performance. The "ground truth" for this device would be its adherence to established engineering specifications and safety standards, and its functional similarity to predicate devices, verified through various physical and functional tests (not explicitly detailed in the summary).
The sample size for the training set:
- Not applicable. This device is not an AI algorithm that requires a "training set."
How the ground truth for the training set was established:
- Not applicable.

In summary: The provided 510(k) summary focuses on demonstrating "substantial equivalence" of the new Ceralas Multiwavelength 980/1470nm Diode Laser System to existing predicate devices (Cynosure Smart Lipo Multiwavelength Laser, Biolitec Ceralas 980nm Diode Laser, and Biolitec Ceralas 1470nm Diode Laser). This regulatory pathway relies on showing that the new device has the same intended use, similar indications for use, similar technological characteristics, and similar principles of operation, and that any minor technological differences do not raise new issues of safety or effectiveness. The "performance data" mentioned refers to testing done to confirm these similarities, not to a clinical study with specific acceptance criteria or ground truth establishment as would be common for AI/diagnostic devices.

Summary

{0}------------------------------------------------

090164 Page (1) of (5)

510(k) SUMMARY

Biolitec Inc.'s Ceralas Multiwavelength 980/1470nm Diode Laser System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Hogan & Hartson 555 13th Street NW Washington DC 20004

JUN 26 2009

(202) 637-5794 Phone: Facsimile: (202) 637-5910

Jonathan S. Kahan Contact Person:

January 21, 2009 Date Prepared:

Name of Device and Name/Address of Sponsor

Ceralas Multiwavelength 980/1470nm Diode Laser

Biolitec, Inc. 515 Shaker Road East Longmeadow, MA 01028

Common or Usual Name

Diode Laser

Classification Name

Laser, Surgical Diode Laser System, 21 C.F.R. 878.4810, Product Code GEX

Predicate Devices

Cynosure Smart Lipo Multiwavelength Laser (K080121) Biolitec Ceralas 980nm Diode Laser (K072106) Biolitec Ceralas 1470nm Diode Laser (K073063)

\ \ \ \ DC - 061213/00001 - 2831829 v2

{1}------------------------------------------------

090164 page (2) of (5)

Intended Use / Indications for Use

The device is specifically indicated for use as follows:

Ear, Nose and Throat and Oral Surgery (Otolaryngology)

Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:

. Removal of benign lesions from the ear, nose and throat
Excision and vaporization of vocal cord nodules and polyps .
. Incision and excision of carcinoma in situ
Ablation and vaporization of hyperkeratosis .
Excision of carcinoma of the larynx .
. Laryngeal papillomectomy
Excision and vaporization of herpes simplex I and II ●
Neck dissection .

Arthroscopy

Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:

Menisectomy
. Synovectorny
Chondromalacia ●

Gastroenterology

Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include:

. Hemostasis of upper and lower GI bleeding
. Excision and vaporization of colorectal carcinoma
� Excision of polyps

{2}------------------------------------------------

K090164 Page 3 of (5)

General Surgery, Dermatology, Plastic Surgery and Podiatry

Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples include:

Matrixectomy .
Excision of neuromas .
Excision of periungual and subungual warts ●
Excision of plantar warts �
Excision of keloids �
. Liver resection
. Excision of cutaneous lesions
. Hemorrhoidectomy
. Appendectomy
. Debridement of decubitus ulcers
. Hepatobiliary tumors
. Mastectomy
. Dermabrasion
. Vaporization and hemostasis of capillary hemangioma
Excision, vaporization and hemostasis of abdominal tumors .
. Excision, vaporization and hemostasis of rectal pathology
Pilonidal cystectomy .
. Herniorapphy

. Adhesiolysis

. Parathyroidectomy
. Laparoscopic cholecystectomy
. Thyroidectomy
. Resection of organs
. Debridement of wounds
Photocoagulation of teleangectasia of the legs and face .
Photocoagulation of vascular lesions of the face and extremities .
Endovascular coagulation of the greater saphenous vein of the thigh in ● patients with superficial vein reflux.
. Treatment of reticular veins and branch varicosities

Urology

Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include:

Vaporization of urethral tumors .
Release of urethral stricture .
. Removal of bladder neck obstruction
Excision and vaporization of condyloma .
Lesions of external genitalia ●
Vaporization of the prostate to treat benign prostatic hyperplasia (BPH) .

{3}------------------------------------------------

090164 Page (4) of (5)

Gynecology

Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:

Endometrial ablation .
Excision or vaporization of condylomata acuminate .
Vaporization of cervical intraepithelial neoplasia .
Cervical conization .
Menorrhagia �

Neurosurgery

Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas

Cardiac Surgery

Hemostasis and coagulation of soft tissue, including cardiac tissue.

Pulmonary Surgery

Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:

. Tracheobronchial malignancy or stricture
Benign and malignant pulmonary obstruction .
Endoscopic pulmonary applications �

Dental Applications

Indicated for the following applications on intraoral and extraoral soft tissue (including marginal and interdental gingival and epithelial lining of free gingival): frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux

Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

{4}------------------------------------------------

091164 Page (5) of (5)

Technological Characteristics

The Ceralas Multiwavelength 980/1470 Diode Laser emits laser energy at the 980nm and 1470nm wavelengths in a manner substantially similar to the Ceralas 980 and Ceralas 1470.

Performance Data

Performance testing of the Ceralas Multiwavelength 980/1470 Diode Laser demonstrates no significant difference as compared to the cleared predicate devices.

Substantial Equivalence

The Ceralas Multiwavelength 980/1470nm Diode Laser is substantially equivalent to the Cynosure Smart Lipo Multiwavelength Laser, the Biolitec Ceralas 980mm Diode Laser and the Ceralas 1470nm Diode Laser. The Ceralas Multiwavelength 980/1470mm Diode Laser has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between the Ceralas Multiwavelength 980/1470mm Diode Laser and its predicate devices raises no new issues of safety or effectiveness. Thus, the Ceralas Multiwavelength 980/1470nm Diode Laser is substantially equivalent.

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

JUN 26 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biolitec, Inc. % Hogan & Hartson LLP Mr. Jonathan S. Kahan Columbia Square 555 13th Street Northwest Washington, District of Columbia 20004

Re: K090164

Trade/Device Name: Ceralas Multiwavelength 980/147nm Diode Laser Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: June 2, 2009

Dear Mr. Kahan:

Received: June 3, 2009

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

{6}------------------------------------------------

Page 2 - Mr. Jonathan S. Kahan

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,
Mark McMillan

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Indications for Use Statement

510(k) Number (if known):_	KC
----------------------------	----

Device Name: Ceralas Multiwavelength 980/1470nm Diode Laser

90164

Indications for Use:

The device is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures including via endoscopes. The Ceralas Multiwavelength 980/1470 Diode Laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, cardiothoracic surgery, dental applications, and endovenous occlusion of the greater saphenous vein. Multiwavelength laser is further indicated for laser assisted lipolysis

The device is specifically indicated for use as follows:

Ear, Nose and Throat and Oral Surgery (Otolaryngology)

Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue from the ear, nose, throat and adjacent areas including soft tissue in the oral cavity. Examples include:

Removal of benign lesions from the ear, nose and throat .
Excision and vaporization of vocal cord nodules and polyps
Incision and excision of carcinoma in situ
Ablation and vaporization of hyperkeratosis
Excision of carcinoma of the larynx
Laryngeal papillomectomy
Excision and vaporization of herpes simplex I and II
Neck dissection

Arthroscopy

Hemostasis, incision, excision, coagulation, vaporization and ablation of joint tissues during arthroscopic surgery. Examples include:

Menisectomy
Synovectomy
Chondromalacia

Gastroenterology

Hemostasis, incision, excision, ablation, coagulation and vaporization of tissue in the upper and lower gastrointestinal tracts and also with endoscopic procedures. Examples include: منها

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

\DĊ. 061218/000001 - 2831829 v2

510(k) Number K090164

{8}------------------------------------------------

K090164

Page ② of ④

Hemostasis of upper and lower GI bleeding
Excision and vaporization of colorectal carcinoma
Excision of polyps

General Surgery, Dermatology, Plastic Surgery and Podiatry

Matrixectomy
Excision of neuromas
Excision of periungual and subungual warts
Excision of plantar warts
Excision of keloids
Liver resection
Excision of cutaneous lesions
Hemorrhoidectomy
Appendectomy
Debridement of decubitus ulcers
Hepatobiliary tumors
Mastectomy
Dermabrasion
Vaporization and hemostasis of capillary hemangioma
Excision, vaporization and hemostasis of abdominal turnors
Excision, vaporization and hemostasis of rectal pathology
Pilonidal cystectomy
Herniorapphy
Adhesiolysis
Parathyroidectomy
Laparoscopic cholecystectomy
Thyroidectomy
Resection of organs
Debridement of wounds
Photocoagulation of teleangectasia of the legs and face
Photocoagulation of vascular lesions of the face and extremities
Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
Treatment of reticular veins and branch varicosities ()

Urology

Excision, vaporization, incision, coagulation, ablation and hemostasis of urological tissues. Examples include:

Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090164

\\DC - 061213/000001 - 2831829 v2

{9}------------------------------------------------

KOGJ164

ge of (4)

Vaporization of urethral tumors
Release of urethral stricture
Removal of bladder neck obstruction
Excision and vaporization of condyloma
Lesions of external genitalia
Vaporization of the prostate to treat benign prostatic hyperplasia (BPH)

Gynecology

Ablation, excision, incision, coagulation, hemostasis and vaporization of gynecological tissue. Examples include:

Endometrial ablation .
Excision or vaporization of condylomata acuminate .
Vaporization of cervical intraepithelial neoplasia
Cervical conization
Menorrhagia

Neurosurgerv

Vaporization, coagulation, excision, incision, ablation and hemostasis of soft tissue. Examples include: hemostasis in conjunction with menigiomas

Cardiac Surgery

Hemostasis and coagulation of soft tissue, including cardiac tissue.

Pulmonary Surgery

Hemostasis, vaporization, coagulation, incision, excision and ablation of soft tissue in the pulmonary system. Examples include:

Tracheobronchial malignancy or stricture .
Benign and malignant pulmonary obstruction .
Endoscopic pulmonary applications

Dental Applications

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

\\DC - 061213/000001 - 2831829 v2

510(k) Number_

er K090164

{10}------------------------------------------------

periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy and light activation of bleaching materials for teeth whitening.

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux

Indicated for use with the ELVes Procedure Kit in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

Prescription Use _ X (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (21 C.F.R. 807 Subpart C)

K090164

(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Oslen Jensen

Page 4 of 4

(Division Sign-Oll) (Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K090164

II. II

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.